Enanta Pharmaceuticals Presents Data for its COVID-19 and Respiratory Syncytial Virus Programs at the 33rd European Congress of Clinical Microbiology and Infectious Diseases
April 17 2023 - 7:00AM
Business Wire
- Preclinical Data Demonstrate EDP-235’s Superior Target Tissue
Distribution and Cell Penetration Compared to Other Protease
Inhibitors
- New Preclinical Pharmacokinetic Data Highlight EDP-323’s Strong
Bioavailability and Favorable Tissue Targeting
Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage
biotechnology company dedicated to creating small molecule drugs
for viral infections, today announced the company will present two
posters supporting the continued clinical development of EDP-235,
its 3CL protease inhibitor in development as an oral, once-daily
treatment for SARS-CoV-2 infection, and EDP-323, its L-protein
inhibitor in development as an oral, once-daily treatment for
respiratory syncytial virus (RSV), at the 33rd European Congress of
Clinical Microbiology and Infectious Diseases (ECCMID) being held
April 15-18, 2023 both virtually and at the Bella Center Copenhagen
in Copenhagen, Denmark.
Preclinical data presented demonstrate EDP-235’s preferential
target tissue distribution and cell penetration, enabling EDP-235
to reach potential sites of persistent viral replication, which may
impact progression of long COVID-19. EDP-235 is currently being
evaluated in SPRINT (SARS-Cov-2 PRotease
INhibitor Treatment), a Phase 2 study of
non-hospitalized, symptomatic adults with mild or moderate
COVID-19. Enanta continues to expect topline data from the study in
May 2023. Additionally, preclinical data presented showcase
EDP-323’s favorable preclinical pharmacokinetic (PK) properties,
excellent bioavailability with low plasma clearance, and favorable
target tissue distribution, supporting a once-daily oral dosing
regimen for RSV. EDP-323 is currently being evaluated in a Phase 1
double-blind, placebo-controlled, first-in-human study with a
topline data readout planned for the second quarter of 2023.
“We are pleased to present these data which highlight the strong
and differentiated preclinical profiles of EDP-235 and EDP-323,”
said Jay R. Luly, Ph.D., President and Chief Executive Officer of
Enanta Pharmaceuticals. “Both our EDP-235 and EDP-323 programs are
advancing through clinical development, and we look forward to
presenting our Phase 2 SPRINT trial for EDP-235 and Phase 1 study
for EDP-323 this quarter. Our robust pipeline and important
upcoming milestones move us closer to our vision of developing
important therapies for patients in need.”
Poster #: P2633, Monday, April 17 from
12:00 – 1:30pm CEST “EDP-235, a Potent, Once-Daily,
Oral Antiviral, Demonstrates Potential for Treatment and Prevention
of Long COVID” Yang Li, Ph.D.
Intracellular uptake of EDP-235 compared to nirmatrelvir, the
protease inhibitor in Paxlovid, was evaluated in both rat and human
cells. To determine the in vivo drug distribution into target
tissues, including potential COVID-19 reservoirs: lung, heart,
salivary glands, kidney, adipose tissue and lung alveolar
macrophages, rats were dosed orally with 25 mg/kg of EDP-235 or
nirmatrelvir and plasma and tissue drug levels were analyzed by
liquid chromatography-tandem mass spectrometry. The ratios of
intracellular to extracellular concentrations of EDP-235 in
salivary gland epithelial cells, adipocytes, and macrophages were
11.3, 33.6 and 30.5, respectively, compared to ratios ranged from
0.6 to 1.2 for nirmatrelvir in these human cells. Consistent with
the in vitro observations, EDP-235 showed excellent target tissue
exposure with tissue-to-plasma ratios of 6.5 in salivary glands,
23.0 in adipose tissues, and 28.4 in lung alveolar macrophages,
whereas nirmatrelvir had corresponding values of 0.8, 0.6, and 0.5.
These preclinical data demonstrate that EDP-235 achieved
preferential target tissue distribution and cell penetration,
enabling EDP-235 to target viral reservoirs and minimize viral
persistence, which are important factors potentially related to
some cases of long COVID-19.
Poster #: P2844, Monday, April 17 from
12:00 – 1:30pm CEST “Pharmacokinetics of EDP-323, a
Potent, Once-Daily, Oral Antiviral Treatment for Respiratory
Syncytial Virus” Lisha Xu
The preclinical pharmacokinetic profile of EDP-323, a novel and
potent non-nucleoside RSV L-protein inhibitor, was evaluated in
preclinical species, and human oral absorption and metabolic
stability were tested using Caco-2 cells and human liver
microsomes, respectively. To determine the PK profile, a single
intravenous dose of 5 mg/kg or oral dose of 25 mg/kg was
administered in mice, rats, and dogs. Consistent with in vitro
data, EDP-323 had good plasma exposure with an oral bioavailability
of 34.8% in mice, 70.4% in rats, and 50.5% in dogs. Oral absorption
for EDP-323 was 16.1 x 10-6 cm/s with a low plasma clearance of 0.2
L/h/kg. EDP-323 displayed excellent oral bioavailability with low
plasma clearance and demonstrated favorable target tissue
distribution in the lungs and alveolar macrophages, with an
alveolar macrophage-to-plasma ratio of 3.7 in rats without
off-target distribution to the brain. These preclinical data
support the potential of EDP-323 as a convenient, once-daily oral
treatment for RSV.
About Enanta Pharmaceuticals, Inc. Enanta is using its
robust, chemistry-driven approach and drug discovery capabilities
to become a leader in the discovery and development of small
molecule drugs for the treatment of viral infections. Enanta’s
research and development programs include clinical candidates for
the following disease targets: respiratory syncytial virus (RSV),
SARS-CoV-2 (COVID-19) and hepatitis B virus (HBV). Enanta is also
conducting research on a single agent targeting both RSV and human
metapneumovirus (hMPV).
Enanta’s research and development activities are funded by
royalties from hepatitis C virus (HCV) products developed under its
collaboration with AbbVie. Glecaprevir, a protease inhibitor
discovered by Enanta, is part of one of the leading treatment
regimens for curing chronic HCV infection and is sold by AbbVie in
numerous countries under the tradenames MAVYRET® (U.S.) and
MAVIRET® (ex-U.S.) (glecaprevir/pibrentasvir). Please visit
www.enanta.com for more information.
Forward Looking Statements This press release contains
forward-looking statements, including statements with respect to
the prospects for advancement of Enanta’s clinical programs in RSV
and COVID-19. Statements that are not historical facts are based on
management’s current expectations, estimates, forecasts and
projections about Enanta’s business and the industry in which it
operates and management’s beliefs and assumptions. The statements
contained in this release are not guarantees of future performance
and involve certain risks, uncertainties and assumptions, which are
difficult to predict. Therefore, actual outcomes and results may
differ materially from what is expressed in such forward-looking
statements. Important factors and risks that may affect actual
results include: the impact of development, regulatory and
marketing efforts of others with respect to competitive treatments
for RSV or COVID-19; the discovery and development risks of
Enanta’s RSV and COVID-19 programs; the competitive impact of
development, regulatory and marketing efforts of others in this
disease area; any continuing impact of the COVID-19 pandemic on
business operations and clinical trials; Enanta’s lack of clinical
development experience; Enanta’s need to attract and retain senior
management and key research and development personnel; Enanta’s
need to obtain and maintain patent protection for its product
candidates and avoid potential infringement of the intellectual
property rights of others; and other risk factors described or
referred to in “Risk Factors” in Enanta’s Form 10-K for the fiscal
year ended September 30, 2022, and any other periodic reports filed
more recently with the Securities and Exchange Commission. Enanta
cautions investors not to place undue reliance on the
forward-looking statements contained in this release. These
statements speak only as of the date of this release, and Enanta
undertakes no obligation to update or revise these statements,
except as may be required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20230417005226/en/
Media and Investors Contact Jennifer Viera 617-744-3848
jviera@enanta.com
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